Descovy: Uses, Side Effects and Dosage

What is Descovy used for?

Descovy is used to:

• treat HIV infection in adults and children who weigh at least 25 kg (55 lbs)

• help reduce the risk of getting HIV-1 infection in adults and adolescents who weigh at least 35 kg (77 lbs). This is called pre-exposure prophylaxis or PrEP.

  • Descovy for PrEP is not for use in people born female (assigned female at birth) who are at risk of getting HIV-1 infection from vaginal sex, because its effectiveness has not been studied.

Descovy is for people who do not have an HIV virus that is resistant to Descovy.

Descovy has not been studied in children with HIV-1 infection weighing less than 25 kg (55 lbs) or HIV-1 uninfected children weighing less than 35 kg.

For more information on the DESCOVY HIV-1 PrEP Education Program (Important Safety Information for People Taking DESCOVY for PrEP), log onto www.descovyeducation.ca.

How does Descovy work?

Serious Warnings and Precautions

• “Flare-ups” of Hepatitis B Virus infection, in which the disease suddenly returns in a worse way than before, can occur if you have hepatitis B and stop taking Descovy. Do not stop taking Descovy without your doctor’s advice. If you stop taking Descovy, tell your doctor immediately about any new, unusual or worsening symptoms that you notice after stopping treatment. After you stop taking Descovy, your doctor will still need to check your health and take blood tests to check your liver. Descovy is not approved for the treatment of hepatitis B virus infection.
• Descovy should only be used for pre-exposure prophylaxis (PrEP) if you are HIV-negative before and during treatment. Discuss with your healthcare professional if you have had a recent flu-like illness. Your healthcare professional will run tests to confirm that you are HIV-negative before and during Descovy treatment.

Using Descovy to treat HIV-1 Infection:

Descovy lowers the amount of HIV in the blood (viral load).

HIV infection destroys CD4+ (T) cells. These cells are important to help the immune system fight infections. After a large number of T cells are destroyed, acquired immune deficiency syndrome (AIDS) develops.

Descovy may help increase the count of CD4+ (T) cells. Lowering the amount of HIV in the blood and increasing the CD4+ (T) cells lower the chance of getting infections that happen when your immune system is weak.

Descovy does not cure HIV infection or AIDS. The long-term effects of Descovy are not known. People taking Descovy may still get infections or other conditions that happen with HIV infection. Some of these conditions are pneumonia and Mycobacterium avium complex (MAC) infections. It is very important that you see your doctor on a regular basis while taking Descovy.

Using Descovy for HIV-1 PrEP:

Descovy works better to reduce the risk of getting HIV-1 when the medicines are in your bloodstream before you are exposed to HIV-1. Continue to practice safe sex. Use condoms to lower the chance of sexual contact with body fluids such as semen, vaginal secretions, or blood. Do not re-use or share needles.

For more information on the DESCOVY HIV-1 PrEP Education Program (Important Safety Information for People Taking DESCOVY for PrEP), log onto www.descovyeducation.ca.

What are the ingredients in Descovy?

Medicinal ingredients: emtricitabine and tenofovir alafenamide* (* as tenofovir alafenamide hemifumarate)

Non-medicinal ingredients: croscarmellose sodium, magnesium stearate and microcrystalline cellulose. The grey tablets are film-coated with a coating material containing iron oxide black, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. The blue tablets are film-coated with a coating material containing indigo carmine aluminum lake, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.

Descovy comes in the following dosage forms:

Descovy is available as tablets.

Descovy is available as rectangular-shaped, film-coated tablets containing 200 mg of emtricitabine and either 10 mg or 25 mg of tenofovir alafenamide (grey tablets and blue tablets, respectively). Each tablet is debossed with “GSI” on one side and either “210” (200/10 mg strength) or “225” (200/25 mg strength) on the other side. Each bottle contains 30 tablets and a silica gel desiccant and is closed with a child-resistant closure.

Do not use Descovy if:

• you are taking any medication that is listed in this pamphlet under “Drugs that should not be taken with Descovy”
• you are allergic to Descovy or any of its ingredients (see: What are the ingredients in Descovy?).

Do not take Descovy for HIV-1 PrEP if:

• you already have HIV-1 infection. If you are HIV-1 positive, you need to take other HIV-1 medicines with Descovy to treat HIV-1. Descovy by itself is not a complete treatment for HIV-1.
• you do not know your HIV-1 infection status. You may already be HIV-1 positive. You need to take other HIV-1 medicines with Descovy to treat HIV-1 infection.

Descovy can only help reduce your risk of getting HIV-1 infection before you are infected.

To help avoid side effects and ensure proper use, talk to your doctor before you take Descovy. Talk about any health conditions or problems you may have, including if you:

• Have hepatitis B virus (HBV) infection and take Descovy. Your HBV infection may get worse (flare-up) and symptoms worsen if you stop taking Descovy (see Serious Warnings and Precautions box and Serious Side Effects table).
• Have a history of pancreatitis (swelling of the pancreas). If you develop symptoms of pancreatitis, such as nausea, vomiting and severe pain in the abdomen and/or back, contact your doctor.
• Have kidney problems. Kidney problems, including kidney failure, have occurred in patients taking tenofovir. If you have kidney problems and are taking Descovy along with certain medicines such as non-steroidal anti inflammatory drugs, your kidney problems could get worse.
• Have a history of bone fracture, bone loss or osteoporosis. Bone loss has happened in some people who took Descovy.
• Have lactic acidosis (high levels of acid in the blood). See the Serious Side Effects table for symptoms and contact your doctor right away if you get these symptoms.
• Have severe liver problems including enlarged or fatty liver. See the Serious Side Effects table for symptoms and contact your doctor right away if you get these symptoms.

Do not run out of Descovy. Refill your prescription or talk to your doctor before your Descovy is all gone.

Do not stop taking Descovy without first talking to your doctor.

If you have HBV infection and you stop taking Descovy, your doctor will need to check your health often and do blood tests regularly for several months to check your HBV infection. Tell your doctor about any new or unusual symptoms you may have after you stop taking Descovy.

Other warnings you should know about:

If you are pregnant or plan to become pregnant:

It is not known if Descovy can harm your unborn child. You and your doctor will decide if you should take Descovy.

Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. This registry collects information about your health and your baby’s health. If you become pregnant while taking Descovy, talk with your doctor about taking part in this registry.

If you are breastfeeding or plan to breastfeed:

Do not breastfeed if you have HIV because of the chance of passing the HIV virus to your baby. One of the ingredients of Descovy, emtricitabine, can be passed to your baby in your breast milk and may cause harm to your baby. It is not known if the other components can be passed to your baby in breast milk. If you are a woman who has or will have a baby, talk with your doctor about the best way to feed your baby.

Blood Sugar and Fat Levels

Your blood sugar levels (glucose) or level of fats (lipids) in your blood may increase with HIV treatment. Your doctor may order blood tests for you.

Before taking Descovy for HIV-1 PrEP:

• You must be HIV-1 negative to start Descovy. You must get tested to make sure that you do not already have HIV-1 infection.
• Do not take Descovy for HIV-1 PrEP unless you are confirmed to be HIV-1 negative.
• Many HIV-1 tests can fail to pick up that you are HIV-1 infected if you have just recently become infected with HIV-1. If you have flu-like symptoms, you could have recently become infected with HIV-1. Tell your healthcare provider if you had a flu-like illness within the last month before starting Descovy or at any time while taking Descovy. Symptoms of new HIV-1 infection include: tiredness, fever, joint or muscle aches, headache, sore throat, vomiting or diarrhea, rash, night sweats or enlarged lymph nodes in the neck or groin.

For more information on the DESCOVY HIV-1 PrEP Education Program (Important Safety Information for People Taking DESCOVY for PrEP), log onto www.descovyeducation.ca.

While you are taking Descovy for HIV-1 PrEP:

• You must stay HIV-1 negative to keep taking Descovy for HIV-1 PrEP. It is important that you get tested for HIV-1 at least every 3 months or as recommended by your healthcare provider while taking Descovy.
• If you do become HIV-1 positive, you need more medicine than Descovy alone to treat HIV-1. Descovy by itself is not a complete treatment for HIV-1.

For more information on the DESCOVY HIV-1 PrEP Education Program (Important Safety Information for People Taking DESCOVY for PrEP), log onto www.descovyeducation.ca.

If you have HIV-1 and take only Descovy, over time your HIV-1 may become harder to treat.

Avoid doing things that can increase your risk of getting HIV infection or other STIs or spreading HIV infection to other people:

• Do not re-use or share needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
• Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vagina secretions, or blood.

Ask your healthcare professional if you have any questions on how to prevent getting HIV infection or other STIs or spreading HIV infection to other people.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Drugs that should not be taken with Descovy:

• Any other medicines that contain tenofovir alafenamide (BIKTARVY^®, GENVOYA^®, ODEFSEY^®, Symtuza™, VEMLIDY^®).
• Any other medicines that contain tenofovir disoproxil fumarate (ATRIPLA^®, COMPLERA^®, STRIBILD^®, TRUVADA^®, VIREAD^®).
• Any other medicines that contain emtricitabine or lamivudine (ATRIPLA, BIKTARVY, COMPLERA, EMTRIVA^®, GENVOYA, ODEFSEY, STRIBILD, Symtuza, TRUVADA; 3TC, Combivir^®, Heptovir^®, Kivexa^®, Triumeq^®, Trizivir^®).
• adefovir (HEPSERA^®).

Drugs that interact with Descovy and when the dose of Descovy or the dose of the other drug should be changed or further instruction from your doctor are needed:

These are not all the medicines that may cause problems if you take Descovy. Be sure to tell your doctor about all the medicines you take.

Keep a complete list of all the prescription, nonprescription and herbal medicines that you are taking, how much you take and how often you take them. Make a new list when medicines or herbal medicines are added or stopped, or if the dose changes. Give copies of this list to all your doctors and pharmacists every time you visit them or fill a prescription. This will give your doctor a complete picture of the medicines you use. Then he or she can decide the best approach for the situation.

How to take Descovy:

Stay under a doctor’s care when taking Descovy. Do not change your treatment or stop treatment without first talking with your doctor.

When your Descovy supply starts to run low, get more from your doctor or pharmacy. If you are taking Descovy for HIV-1 treatment, this is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. If Descovy is not taken on a regular basis, as prescribed, HIV may become harder to treat.

If you are on dialysis, take your daily dose of Descovy following dialysis.

Only take medicine that has been prescribed specifically for you.

Do not give Descovy to others or take medicine prescribed for someone else.

Do not use if seal over bottle opening is broken or missing.

If you take Descovy for HIV-1 PrEP:

• you must also use other methods to reduce your risk of getting other STIs.
• take Descovy every day, not just when you think you have been exposed to HIV-1.

Usual dose:

For treatment of HIV-1 infection

Adults and children weighing 25 kg or more:

• The usual dose of Descovy is one tablet orally (by mouth) once a day.
• Try to take the tablet at the same time each day. Swallow with plenty of water.

• Take Descovy with or without food.

For prevention of HIV-1 infection (PrEP)

Adults and children weighing 35 kg or more:

• The dose of Descovy is one 200/25 mg tablet orally (by mouth) once a day.
• Try to take the tablet at the same time each day. Swallow with plenty of water.
• Take Descovy with or without food.

Overdose:

Missed Dose:

It is important that you do not miss any doses. If you miss a dose of Descovy and it is less than 18 hours from the time you usually take Descovy, then take the dose. If more than 18 hours has passed from the time you usually take Descovy, then wait until the next scheduled daily dose. Do not take more than 1 dose of Descovy in a day. Do not take 2 doses at the same time. Call your doctor or pharmacist if you are not sure what to do.

If you are taking Descovy for HIV-1 PrEP, missing doses increases your risk of getting HIV-1 infection.

What are possible side effects from using Descovy?

These are not all the possible side effects you may feel when taking Descovy. If you get any side effects not listed here, contact your doctor. Please also see Serious Warnings and Precautions box.

The most common side effects of Descovy are:

• Nausea.
• Diarrhea.
• Headache.
• Fatigue.

Additional side effects may include:

• Gas.
• Swelling in the face, lips, tongue or throat (angioedema).
• Hives (urticaria).

Changes in your immune system (Immune Reconstitution Inflammatory Syndrome) can happen when you start taking HIV-1 medicines for HIV-1 treatment. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time.

Autoimmune disorders (when the immune system attacks healthy body tissue), may also occur after you start taking medicines for HIV infection. Examples of this include: Grave's disease (which affects the thyroid gland), Guillain-Barré syndrome (which affects the nervous system), polymyositis (which affects the muscles), or autoimmune hepatitis (which affects the liver). Autoimmune disorders may occur many months after the start of treatment. Look for any other symptoms such as:

• high temperature (fever), redness, rash or swelling
• joint or muscle pain
• numbness or weakness beginning in the hands and feet and moving up towards the trunk of the body
• palpitations (chest pain) or rapid heart rate

If you notice these or any symptoms of inflammation or infection, tell your doctor immediately.

Bone problems can happen in some people who take Descovy. Bone problems may include bone pain, softening or thinning (which may lead to fractures). Your doctor may need to do tests to check your bones.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

Storage:

• Descovy should be stored below 30°C (86°F). It should remain stable until the expiration date printed on the label.
• Keep Descovy in its original container and keep the container tightly closed.
• Keep out of reach and sight of children.

If you want more information about Descovy:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.gilead.ca); or by calling 1-866-207-4267.

Last Revised: August 5, 2022

Gilead Sciences, Inc. Foster City, CA 94404 USA

Gilead Sciences Canada, Inc. Mississauga, ON L5N 2W3

ATRIPLA^®, BIKTARVY^®, COMPLERA^®, DESCOVY^®, EMTRIVA^®, GENVOYA^®, HEPSERA^®, ODEFSEY^®, STRIBILD^®, TRUVADA^®, VEMLIDY^®, and VIREAD^® are trademarks of Gilead Sciences, Inc. or its related companies.

All other marks referenced herein are the property of their respective owners.

© 2022 Gilead Sciences, Inc.

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